Chief Clinical Product Officer (Indiana)
Intelligent precision medicine company is seeking a Chief Clinical Product Officer (CCPO) to implement the Company’s approved clinical product roadmap. The CCPO will lead clinical execution across products integrating pharmaceutical therapies, drug-delivery systems, connected devices, digital biomarkers, longitudinal patient data, Generative AI, agentic AI, predictive and adaptive machine learning, edge computing, multimodal sensing, and proprietary clinical intelligence systems. Working within the Company’s product-development organization, the CCPO will ensure that clinical products are developed, validated, governed, and commercialized in accordance with approved priorities, clinical objectives, quality standards, applicable regulatory requirements, and patient-safety and provider-safety commitments. The CCPO will collaborate with clinical, product, AI/ML, engineering, quality, regulatory, human-factors, cybersecurity, data-science, commercial, and implementation teams. The role requires strong execution, clinical judgment, cross-functional leadership, and timely escalation of risks affecting patient safety, product quality, regulatory readiness, or commercialization. Clinical activities will be integrated into the Company’s product-development lifecycle, design controls, risk-management and quality systems, software-development processes, verification and validation activities, change control, and post-market processes. Applicable regulations, recognized standards, Company procedures, and relevant guidance will be addressed on a product-specific basis, including, as applicable, ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 81001-5-1, Good Clinical Practice, data-protection requirements, and FDA or international AI/ML guidance. Regulatory leadership and final regulatory accountability remain with the CEO and designated Company leadership. The CCPO will provide clinical input, support regulatory activities, and execute assigned clinical responsibilities in coordination with those leaders. Key Responsibilities Clinical Product Execution Translate product priorities into clinical requirements, intended uses, workflows, endpoints, acceptance criteria, development plans, and milestones. Integrate clinical requirements into product, system, software, user, risk-control, verification, validation, labeling, and post-market plans. Coordinate clinical execution across product, clinical, AI/ML, engineering, quality, regulatory, human-factors, cybersecurity, and commercial teams. Define the clinical role of AI-enabled capabilities, including detection, prediction, recommendations, patient support, professional review, and predefined therapeutic actions. Identify dependencies, resource needs, and execution risks. Escalate material clinical, safety, quality, product, or regulatory concerns to the CEO and appropriate governance bodies. Product Development and Compliance Partner with Product, Engineering, Quality, and Regulatory leaders on product-specific compliance plans. Maintain appropriate clinical documentation in technical files, clinical evaluation reports, risk-management files, software lifecycle records, usability files, cybersecurity documentation, and related records. Participate in design reviews, stage gates, risk reviews, release-readiness reviews, change-control boards, and clinical governance meetings. Ensure that model updates, new data sources, new populations, expanded indications, changed thresholds, and increased autonomy undergo appropriate risk, verification, validation, change-control, and regulatory assessment. Support audit and inspection readiness through complete, traceable, and consistent documentation. Clinical Development and Evidence Oversee feasibility studies, algorithm-development studies, human-factors studies, clinical validation studies, prospective trials, decentralized studies, and real-world evidence programs. Define patient populations, endpoints, comparators, study objectives, success criteria, and evidence requirements. Ensure AI validation addresses clinical performance, safety, usability, generalizability, clinical utility, workflow impact, and real-world effectiveness - not only technical accuracy. Oversee investigators, clinical research organizations, protocols, monitoring, data management, endpoint adjudication, safety reporting, statistical analysis, and clinical study reports. Ensure evidence is generated under applicable Good Clinical Practice, human-subject protection, privacy, data-integrity, and Company quality requirements. Support regulatory submissions, publications, payer discussions, partnerships, and evidence-based commercial communications. Clinical Quality, Safety, and Governance Incorporate clinical quality and patient-safety requirements into design, development, verification, validation, release, and lifecycle management. Establish clinical guardrails for uncertainty, incomplete data, hallucinations, false-positive and false-negative outputs, automation bias, population bias, model drift, delayed data, inadequate escalation, and unexpected AI behavior. Define requirements for professional supervision, patient or caregiver use, and autonomous or semi-autonomous actions. Maintain traceability among clinical needs, intended use, requirements, risks, controls, validation evidence, labeling, and claims. Review adverse events, complaints, near misses, safety signals, unexpected AI behavior, and post-market trends. Monitor clinical performance, model performance, calibration, escalation rates, adherence, workflow impact, health equity, resource utilization, model drift, data shifts, cybersecurity-related clinical risks, and changes in benefit-risk. Regulatory, Implementation, and Commercial Support Provide clinical input to regulatory strategies for AI-enabled medical devices, software as a medical device, connected drug-delivery systems, combination products, digital biomarkers, and related platforms. Support FDA meetings, pre-submissions, investigational submissions, marketing applications, agency responses, audits, inspections, and post-market commitments under the direction of the CEO and designated regulatory leadership. Support clinically defensible intended uses, indications, claims, performance requirements, limitations, warnings, and labeling. Work with commercial and market-access teams on product positioning, reimbursement strategies, value propositions, and customer adoption. Ensure commercialization preserves approved patient-selection criteria, clinical controls, escalation pathways, user qualifications, and risk mitigations. Advise the CEO and Board on execution progress, clinical risk, patient safety, evidence, quality, regulatory readiness, compliance, and commercialization. Build and lead the clinical product organization. Manage clinical product priorities, budgets, staffing, vendors, investigators, research partners, and operating plans within the approved roadmap. Provide independent clinical judgment when technical, commercial, financial, or timeline pressures could create unacceptable risk. Recommend roadmap changes when supported by clinical evidence, safety findings, regulatory developments, applicable standards, or material changes in feasibility. Communicate clinical product recommendations clearly to the CEO, Board, and relevant Company leaders. Required Qualifications Ph.D. or M.D. is required. Significant senior leadership experience in clinical product development, clinical development, clinical quality, medical devices, digital health, biopharmaceuticals, combination products, clinical informatics, healthcare technology, or AI-enabled clinical products. Demonstrated experience executing clinical product roadmaps and translating priorities into requirements, development plans, validation activities, and evidence programs. Experience in formal product-development, design-control, quality-management, risk-management, software-lifecycle, or regulated medical-product environments. Working knowledge of applicable medical-device and healthcare-product regulations, standards, Good Clinical Practice, clinical evaluation, cybersecurity, and AI/ML guidance. Experience designing, conducting, overseeing, or evaluating clinical studies supporting safety, effectiveness, regulatory review, commercialization, or reimbursement. Experience leading multidisciplinary teams involving clinicians, AI/ML scientists, data scientists, engineers, software developers, human-factors specialists, quality professionals, and regulatory professionals. Working knowledge of AI/ML validation, bias, generalizability, performance monitoring, model drift, change management, and lifecycle management. Strong understanding of clinical safety, product quality, evidence standards, responsible AI, and patient-facing technology risks. Preferred Qualifications Clinical-practice experience or substantial experience working with clinicians, health systems, payers, or healthcare-delivery organizations. Experience developing or commercializing FDA-regulated AI/ML-enabled medical devices, software as a medical device, digital therapeutics, connected devices, combination products, or drug-delivery technologies. Experience with Generative AI, agentic AI, multimodal AI, digital biomarkers, remote patient monitoring, edge AI, predictive analytics, or clinical decision support.
